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N/A Completed N=52 Randomized Double-blind Treatment

A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.

Source: ClinicalTrials.gov NCT03951610 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants With Lens Centration — 17; 12; 34; 39 Participants

Summary

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Lens Centration
20; 16; 31; 36; 1; 0
PRIMARY
Post Blink Movement
0.26; 0.25
PRIMARY
Primary Gaze Lag
0.23; 0.22
PRIMARY
Up Gaze Lag
0.28; 0.29
PRIMARY
Push-Up Tightness
45; 48
PRIMARY
Overall Fit Acceptance
3.12; 3.13
PRIMARY
Number of Participants With Overall Lens Fit Impression
0; 1; 9; 9; 41; 41
SECONDARY
Subjective Comfort Rating
9.1; 9.1

Eligibility Criteria

Inclusion Criteria

  • Has had a self-reported oculo-visual examination in the last two years.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  • Currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
  • Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).
  • Has no more than 0.75 diopters of refractive astigmatism.
  • Has clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination.
  • Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

Exclusion Criteria

  • Is presently participating in any other clinical or research study including eye related clinical or research study.
  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
  • Has any known sensitivity to fluorescein dye or products to be used in the study.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03951610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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